Scholars@Duke

On assessing bioequivalence using genomic data with model misspecification.

Publication ,  Journal Article
Lu, Q; Tse, S-K; Chow, S-C; Yang, J
Published in: J Biopharm Stat
July 2009
Published version (DOI) Link to item

This study considers the effect of a nonlinear relationship between pharmacokinetic (PK) and genomic data on bioequivalence assessment using genomic data. A true relationship between PK and genomic data is assumed to be quadratic, but a linear relationship is used instead to assess bioequivalence. Based on this misspecified model, we compare the corresponding power function and sample size for testing average bioequivalence (ABE) to those based on the true model. A numerical study is performed to explore the effect of the misspecification.

Duke Scholars

Shein-Chung Chow
Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics

Published In

J Biopharm Stat

DOI

10.1080/10543400902963177

EISSN

1520-5711

Publication Date

July 2009

Volume

19

Issue

4

Start / End Page

571 / 579

Location

England

Related Subject Headings

  • Therapeutic Equivalency
  • Statistics & Probability
  • Sample Size
  • Reproducibility of Results
  • Pharmacokinetics
  • Pharmacogenetics
  • Numerical Analysis, Computer-Assisted
  • Nonlinear Dynamics
  • Models, Statistical
  • Linear Models
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Lu, Q., Tse, S.-K., Chow, S.-C., & Yang, J. (2009). On assessing bioequivalence using genomic data with model misspecification. J Biopharm Stat, 19(4), 571–579. https://doi.org/10.1080/10543400902963177
Lu, Qingshu, Siu-Keung Tse, Shein-Chung Chow, and Jun Yang. “On assessing bioequivalence using genomic data with model misspecification.” J Biopharm Stat 19, no. 4 (July 2009): 571–79. https://doi.org/10.1080/10543400902963177.
Lu Q, Tse S-K, Chow S-C, Yang J. On assessing bioequivalence using genomic data with model misspecification. J Biopharm Stat. 2009 Jul;19(4):571–9.
Lu, Qingshu, et al. “On assessing bioequivalence using genomic data with model misspecification.” J Biopharm Stat, vol. 19, no. 4, July 2009, pp. 571–79. Pubmed, doi:10.1080/10543400902963177.
Lu Q, Tse S-K, Chow S-C, Yang J. On assessing bioequivalence using genomic data with model misspecification. J Biopharm Stat. 2009 Jul;19(4):571–579.

Published In

J Biopharm Stat

DOI

10.1080/10543400902963177

EISSN

1520-5711

Publication Date

July 2009

Volume

19

Issue

4

Start / End Page

571 / 579

Location

England

Related Subject Headings

  • Therapeutic Equivalency
  • Statistics & Probability
  • Sample Size
  • Reproducibility of Results
  • Pharmacokinetics
  • Pharmacogenetics
  • Numerical Analysis, Computer-Assisted
  • Nonlinear Dynamics
  • Models, Statistical
  • Linear Models